The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.

The purpose of this study is to determine whether Nivolumab plus Ipilimumab has preliminary evidence of safety and effectiveness in the treatment of participants with metastatic castration-resistant prostate cancer who have progressed after prior Docetaxel-containing regimen.

Overall Survival (OS) [ Time Frame: Up to 5 years from treatment initiation ]

Number of participants with adverse events [ Time Frame: From first dose up to and including 100 days post last dose ]

Number of participants with serious adverse events [ Time Frame: From first dose up to and including 100 days post last dose ]

Number of participants with adverse events leading to discontinuation [ Time Frame: From first dose up to and including 100 days post last dose ]

Number of participants with immune-mediated adverse events [ Time Frame: From first dose up to and including 100 days post last dose ]

Number of participants with deaths [ Time Frame: From first dose up to and including 100 days post last dose ]

Number of participants with laboratory abnormalities [ Time Frame: From first dose up to and including 100 days post last dose ]

Number of participants with changes in pain as measured by Brief Pain Inventory-Short Form (BPI-SF) [ Time Frame: Approximately 12 months from treatment initiation ]

Estimated changes in health status and health utility as measured by the 3-level EuroQol Five Dimensions (EQ-5D-3L) [ Time Frame: Approximately 12 months from treatment initiation ]

Changes in cancer related symptoms and quality of life using the Functional Assessment Of Cancer Therapy - Prostate (FACT-P) questionnaire [ Time Frame: Approximately 24 months from treatment initiation ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Prior whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow. Bone-directed radiotherapy for palliation of painful bone metastases to pelvic region is allowed up to 14 days before treatment assignment.